AIDS Clinical Trial
Official title:
Comparison of Facility and Home-based ART Delivery Systems in Uganda
The study is a 3-year, randomized trial to compare ART delivery through two different models: a) ART delivered through health facilities by clinically qualified staff and b) home-based care in which lay workers, i.e. non-medically qualified people, play a major role in the ART delivery and clients are followed up at health facilities less frequently. The primary objective is to measure the effects of these strategies on HIV viral load. We will also examine the effects on treatment failure, disease progression, survival, adherence, family member HIV testing, sexual behavior, and cost-effectiveness.
The study is a randomized trial to compare ART delivery through two different models: a) ART
delivered through health facilities by clinically qualified staff and b) home-based care in
which lay workers, i.e. non-medically qualified people, play a major role in the ART
delivery and clients are followed up at health facilities less frequently. The primary
objective is to measure the effects of these strategies on plasma HIV viral load. We will
also examine the effects on treatment failure, disease progression, survival, adherence,
family member HIV testing, sexual behavior, and cost-effectiveness.
The trial is conducted with The AIDS Support Organization (TASO) clinic in Jinja, Uganda.
Randomization is conducted through geographic clusters, defined using sub-counties in the
district, and stratified by distance from fixed health facilities, and urban/rural. Just
over 800 participants, living in 40 clusters, will be recruited over a period of 3-6 months
and followed-up over a period of 3 years.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
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